Herpes Zoster Vaccine for Lupus Patients

Safety of the Herpes Zoster Subunit Vaccine in Lupus

Recruiting Phase 4 Interventional Study
Systemic Lupus Erythematosus
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
224 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for

This trial is looking for adults with Systemic Lupus Erythematosus who are interested in participating in a study about a herpes vaccine. Participants will receive either the herpes vaccine or a placebo and will be monitored for safety and immune response.

Are You a Good Fit for This Trial?
Rules you out Primary immunodeficiencySecondary immunodeficiency

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with Systemic Lupus Erythematosus.
  • I can provide informed consent to take part in this trial.
  • I use an effective method to prevent pregnancy if I am female.

You may not be able to join if

  • I have had a herpes zoster vaccine or chickenpox vaccine before.
  • I have a herpes infection within the last 12 months.
  • I have been having a significant lupus flare recently.
  • I received any vaccines in the last six weeks.
  • I have received certain treatments for lupus like rituximab or cyclophosphamide recently.
  • I have had a severe fever or used antibiotics in the past month.
  • I am pregnant, breastfeeding, or planning to become pregnant while in the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female or male ≥18 years of age at the time of signing the informed consent 3. Meet the 2019 EULAR/ACR Classification Criteria for SLE 4. Female subjects must use 1 effective method of avoiding pregnancy,…
Contacts

Thomas Chalothron

646-501-7384

Thomas.Chalothron@nyulangone.org

CONTACT

Janine Sullivan

646-501-7390

Janine.Sullivan@nyulangone.org

CONTACT